Treprostinil Medicine 07 December 2022 Extended indication Behandeling van idiopatische of erfelijke primaire pulmonale arteriële hypertensie bij matig-ernstig hartfalen (NYHA-klasse III). Therapeutic value Possible equal value Total cost Registration phase No registration expected Product Active substance Treprostinil Domain Cardiovascular diseases Reason of inclusion Generic G Main indication Other medication for cardiovascular diseases Extended indication Behandeling van idiopatische of erfelijke primaire pulmonale arteriële hypertensie bij matig-ernstig hartfalen (NYHA-klasse III). Current proprietary name Remodulin (Ferrer Interdancional SA) Already available biosimilars / generics Geen Proprietary name Orepaxam Manufacturer Ferrer Internat Portfolio holder Mechanism of action Vasodilator Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Meerdere toedieningsvormen beschikbaar, onbekend welke toedieningsvorm deze generiek zal hebben. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date June 2022 Expected Registration Orphan drug Unknown Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Geen SPC geldig, wel meerdere patenten op het proces om tot de werkzame stof te komen en een patent op prodrugs van treprostinil. Deze laatste verloopt per 12/01/2034. In november 2022 heeft de fabrikant de registratieaanvraag teruggetrokken. De fabrikant verwachtte dat de CHMP om meer klinische data zou vragen die zij niet binnen afzienbare tijd zouden kunnen leveren. Therapeutic value Current treatment options Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks